PMID- 22975216
OWN - NLM
STAT- MEDLINE
DCOM- 20130227
LR  - 20181202
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 49
IP  - 1
DP  - 2013 Jan
TI  - Adjuvant therapy with pegylated interferon alfa-2b (36 months) versus low-dose 
      interferon alfa-2b (18 months) in melanoma patients without macrometastatic 
      nodes: an open-label, randomised, phase 3 European Association for 
      Dermato-Oncology (EADO) study.
PG  - 166-74
LID - S0959-8049(12)00601-6 [pii]
LID - 10.1016/j.ejca.2012.07.018 [doi]
AB  - AIM: Both low-dose interferon (IFN) alfa-2b and pegylated interferon (Peg-IFN) 
      alfa-2b have been shown to be superior to observation in the adjuvant treatment 
      of melanoma without macrometastatic nodes, but have never been directly compared. 
      Peg-IFN facilitates prolongation of treatment, which could provide additional 
      benefit. This multicentre, open-label, randomised, phase 3 trial compared 
      standard low-dose interferon IFN and prolonged treatment with Peg-IFN. PATIENTS 
      AND METHODS: Patients with resected melanoma >/=1.5mm thick and without clinically 
      detectable node metastases were randomised 1:1 to treatment with IFN 3 MU 
      subcutaneously (SC) three times weekly for 18 months or Peg-IFN 100 mug SC once 
      weekly for 36 months. Sentinel lymph node dissection (SLND) was optional. The 
      primary endpoint was disease-free survival (DFS). Secondary endpoints included 
      distant metastasis-free survival (DMFS), overall survival (OS) and adverse events 
      (AEs) grade 3-4. RESULTS: Of 898 patients enrolled, 896 (443 Peg-IFN, 453 IFN) 
      were eligible for evaluation (median follow-up 4.7 years). SLND was performed in 
      68.2% of patients. There were no statistical differences between the two arms for 
      the primary outcome of DFS (hazard ratio [HR] 0.91, 95% confidence interval [CI] 
      0.73-1.15) or the secondary outcomes of DMFS (HR 1.02, 95% CI 0.80-1.32) and OS 
      (HR 1.09, 95% CI 0.82-1.45). Peg-IFN was associated with higher rates of grade 
      3-4 AEs (47.3% versus 25.2%; p<0.0001) and discontinuations (54.3% versus 30.4%) 
      compared with IFN. CONCLUSION: This trial did not show superiority for adjuvant 
      Peg-IFN over conventional low-dose IFN in melanoma patients without clinically 
      detectable nodes. ClinicalTrials.gov identifier: NCT00221702.
CI  - Copyright (c) 2012. Published by Elsevier Ltd.
FAU - Grob, Jean Jacques
AU  - Grob JJ
AD  - Aix-Marseille University, CRO2, Service de Dermatologie, Hopital de Timone, 264 
      Rue St Pierre, 13885 Marseille CEDEX 05, Marseille, France. 
      jean-jacques.grob@ap-hm.fr
FAU - Jouary, Thomas
AU  - Jouary T
FAU - Dreno, Brigitte
AU  - Dreno B
FAU - Asselineau, Julien
AU  - Asselineau J
FAU - Gutzmer, Ralf
AU  - Gutzmer R
FAU - Hauschild, Axel
AU  - Hauschild A
FAU - Leccia, Marie Therese
AU  - Leccia MT
FAU - Landthaler, Michael
AU  - Landthaler M
FAU - Garbe, Claus
AU  - Garbe C
FAU - Sassolas, Bruno
AU  - Sassolas B
FAU - Herbst, Rudolf A
AU  - Herbst RA
FAU - Guillot, Bernard
AU  - Guillot B
FAU - Chene, Genevieve
AU  - Chene G
FAU - Pehamberger, Hubert
AU  - Pehamberger H
LA  - eng
SI  - ClinicalTrials.gov/NCT00221702
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120910
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Interferon alpha-2)
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - G8RGG88B68 (peginterferon alfa-2b)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Chemotherapy, Adjuvant
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Interferon alpha-2
MH  - Interferon-alpha/*therapeutic use
MH  - Kaplan-Meier Estimate
MH  - Lymphatic Metastasis/pathology
MH  - Male
MH  - Melanoma/*drug therapy/pathology
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Polyethylene Glycols/*therapeutic use
MH  - Recombinant Proteins/therapeutic use
MH  - Skin Neoplasms/*drug therapy/pathology
MH  - Young Adult
EDAT- 2012/09/15 06:00
MHDA- 2013/02/28 06:00
CRDT- 2012/09/15 06:00
PHST- 2012/06/07 00:00 [received]
PHST- 2012/07/08 00:00 [accepted]
PHST- 2012/09/15 06:00 [entrez]
PHST- 2012/09/15 06:00 [pubmed]
PHST- 2013/02/28 06:00 [medline]
AID - S0959-8049(12)00601-6 [pii]
AID - 10.1016/j.ejca.2012.07.018 [doi]
PST - ppublish
SO  - Eur J Cancer. 2013 Jan;49(1):166-74. doi: 10.1016/j.ejca.2012.07.018. Epub 2012 
      Sep 10.